(198 days)
The intended use of the temperature probes is to measure temperature by a resistor that is sensitive to temperature changes. The probe is connected to the patient monitor by using an interconnect cable. These probes have skin or core contact with a patient.
Skin probe (SSP 400 and SSP 700): The Skin Sensor Probe is indicated for use in the routine monitoring of skin temperature. It is individually packaged. The skin temperature probe is designed for use with Data Scope, Protocol and DeBusk monitoring systems and other monitors capable with 400 Series temperature probes. The device is indicated for use by qualified medical personnel only.
GP Probes (GP 9400, GP 9700 and GP 14400): The General Purpose Temperature Probe is intended for continuous temperature monitoring. The probe is inserted into the nasopharynx, mouth or the rectum. It is individually packaged. The temperature probe beneath the cuff at the distal tip is designed for use with Data Scope, Protocol and DeBusk monitoring systems and other monitors capable with 400 Series temperature probes. The device is indicated for use by qualified medical personnel only.
Tympanic Probe (TP 400 and TP 700: The Tympanic Probe is intended for monitoring patient temperature through the outer auditory ear canal. It is individually packaged. The tympanic Probe is designed for use with Data Scope, Protocol and DeBusk monitoring systems and other monitors capable with 400 Series temperature probes. The device is indicated for use by qualified medical personnel only.
The intended use of the temperature probes is to measure temperature by a resistor that is sensitive to temperature changes. The probe is connected to the patient monitor by using an interconnect cable. These probes have skin or core contact with a patient.
This document is an FDA 510(k) clearance letter for temperature probes and does not contain detailed information about acceptance criteria or a specific study proving the device meets those criteria. It states that the device is substantially equivalent to legally marketed predicate devices.
Therefore, I cannot provide accurate answers to the questions based on the provided text. The document refers to the general controls provisions of the Act, which cover manufacturing practices, labeling, and other regulations, but it does not detail specific performance acceptance criteria or study methodologies.
§ 880.2910 Clinical electronic thermometer.
(a)
Identification. A clinical electronic thermometer is a device used to measure the body temperature of a patient by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. The transducer may be in a detachable probe with or without a disposable cover.(b)
Classification. Class II (performance standards). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter, subject to the limitations in § 880.9 and the following conditions for exemption:(1) Device is not a clinical thermometer with telethermographic functions;
(2) Device is not a clinical thermometer with continuous temperature measurement functions; and
(3) Appropriate analysis and testing (such as that outlined in the currently FDA-recognized editions, as appropriate, of ISO 80601-2-56, “Medical electrical equipment—Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement,” or ASTM E1965, “Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature,” or ASTM E1112, “Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature,” or ASTM E1104, “Standard Specification for Clinical Thermometer Probe Covers and Sheaths”) must validate specifications and performance of the device.